Streamlining Medical Device Quality and Information Security Compliance
A specialist organisation in the South East sought to simplify and reduce the cost of operating an integrated ISO 13485 and ISO 27001 management system. By centralising both standards within the ProActive platform, the business achieved a more efficient, accessible and robust approach to managing medical device quality and information security requirements.
What the Customer Needed to Achieve
To reduce the cost, duplication and complexity associated with maintaining an integrated ISO 13485 Medical Device Quality Management System and ISO 27001 Information Security Management System. The organisation required a clearer, more manageable structure that would improve efficiency and ease of use.
The Benefits Delivered to the Customer
The customer now benefits from a centralised, integrated and easy-to-use ProActive management system that delivers effective compliance with both medical device quality system requirements and information security management controls. This integration simplifies daily operations, supports audit readiness and reduces administrative burden.
Standards and Certifications Managed
The client is certified to:
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ISO 13485:2016
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ISO 27001:2022
How DAT Performance Supported the Project
DAT Performance provided initial consultancy and ProActive compliance system implementation services, establishing a unified management system structure that integrates both standards effectively and supports long-term compliance and usability.
The Outcome
The organisation now operates an easy-to-use and far more effective integrated ISO 13485 and ISO 27001 management system. The streamlined approach reduces overheads, strengthens compliance and supports ongoing operational excellence across both medical device quality and information security.